FDA Law Blog: Biosimilars

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

RX Note

NOVEMBER 18, 2023

External Links KDIGO CPG for Anemia in Chronic Kidney Disease, 2012 KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease, 2006 KDOQI US Commentary on the 2012 KDIGO Clinical Practice Guideline for Anemia in CKD, 2013 Recombinant human erythropoietins: very rare risk of severe cutaneous adverse (..)

Adverse Reactions 40

Adverse Reactions 40

The Thyroid Pharmacist

SEPTEMBER 8, 2023

Or, you may invest in some supplements and medications, only to discover you have an adverse reaction to them. Or, you may even be scared to try a new intervention in case you have an adverse reaction to it. You may want to feel better and reclaim your life, but you may not know where to even start. Can you relate?

Health and Personal Care Stores 98

Health and Personal Care Stores Adverse Reactions Compounding Immunity 98

The Thyroid Pharmacist

SEPTEMBER 1, 2023

Izuora 2011; Whyte 2006; USDA 2005). Who is Likely to Have an Adverse Reaction to Fluoride, and What are the Symptoms? As a result, tea drinks invariably contain high levels of fluoride. In the United States, brewed black tea averages about 3 to 4 ppm fluoride, while commercial iced tea drinks contain between 1 and 4 ppm.

Adverse Reactions 116

Adverse Reactions Compounding Chemotherapy Labelling 116

The Thyroid Pharmacist

JULY 8, 2022

If you do have an adverse reaction to selenium (again, this is very rare), you may find that you have an iodine deficiency. That said, I have heard from a few clients and readers that adding selenium in the presence of low iodine levels has made them feel worse. The Journal of Clinical Endocrinology and Metabolism. doi: 10.1210/jc.2006-1821.

Dosage 59

Dosage Immunization Immunity Diabetes 59

The Thyroid Pharmacist

JULY 20, 2023

Some people may have adverse reactions to iron. 2006 Feb 15;107(4):1673-9. [25] Raising iron levels can be tricky for a number of reasons… Some people can’t absorb iron despite an adequate diet. Some people don’t tolerate iron supplements. Some people don’t absorb or utilize iron because of other deficiencies.

Health and Personal Care Stores 95

Health and Personal Care Stores HIV Treatment and Prevention Agents Immunity Immunization 95